The LumiraDx SARS-CoV-2 Ab Test is a microfluidic immunofluorescence assay for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (capillary fingerstick or venous), plasma or serum for indication of recent or prior infection. Used with the LumiraDx Platform the Test delivers rapid results at the point of care.
The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test Strip are functioning correctly for every test run.
The workflow process is comprised of a simple sample collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in 11 minutes from sample application.
In clinical studies, fingerstick samples showed 100% positive agreement and 100% negative agreement when collected more than 8 days post RT-PCR.
| Sample collection method | Positive Agreement | Negative Agreement |
|---|---|---|
| Direct Transfer of Fingerstick Blood | 57/57 = 100% | 53/53 = 100% |
| Fingerstick Blood via Transfer Tube | 57/57 = 100% | 55/55 = 100% |
In clinical studies, plasma samples demonstrated an overall 97.2% positive agreement and 100% negative agreement when compared to RT-PCR
| Days from RT-PCR to Blood Collection | Number of Samples | Sensitivity RT-PCR Comparator |
|---|---|---|
| 0-7 days | 17 | 88.2% |
| 8-14 days | 6 | 100% |
| ≥ 15 days | 49 | 100% |
| Total | 72 | 97.2% (95% CI= 90.4% - 99.2%) |
This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
This product has been authorized for use with a test authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Testing of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. Testing of fingerstick whole blood is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.